We incorporate PK/PD strategies within the drug-development plan and apply development solutions and delivery technologies across the entire lifecycle of your product to help drive future growth. Our scientists perform pharmacokinetic and statistical analyses using SAS® and WinNonlin software. Concentration-time data acquired at our Part 11 compliant bioanalytical facility are transferred directly from the Watson LIMS System to WinNonlin for analysis.

PK/PD and Statistical Solutions:

  • Analysis with short turnaround time available
  • Bioequivalence and bioavailability testing
  • Clinical pharmacokinetics
  • Preclinical pharmacokinetics/toxicokinetics
  • Basic PK-PD correlation

To ensure that final reports address your protocol requirements and meet your needs, we develop formal Data Analysis Plans or Statistical Analysis Plans detailing study objectives, methods, and organization and representation of results.

Biostatistical Solutions

  • Design and implementation of randomization scheme
  • Development of Statistical Analysis Plan
  • Sample size rationale and statistical power
  • Methodology for summary and analysis of demographic, baseline, efficacy, and safety data
  • Description of statistical methodology
  • SAS programming for tables, listings, and figures
  • Production of tables, listings and graphs in compliance with ICH guidelines
  • Performance and validation of statistical analyses
  • Interim analysis
  • Bioequivalence
  • Linear and non-linear modeling
  • Parametric and non-parametric analysis of clinical and PK endpoints
  • Production of statistical report/assistance with clinical report
  • Statistical management throughout the project